U.S. patent number 6,814,739 [Application Number 10/146,273] was granted by the patent office on 2004-11-09 for retrieval device.
This patent grant is currently assigned to U.S. Endoscopy Group, Inc.. Invention is credited to Dean J. Secrest, Marlin E. Younker.
United States Patent |
6,814,739 |
Secrest , et al. |
November 9, 2004 |
Retrieval device
Abstract
An endoscopic surgical device for retrieving severed tissue or
foreign bodies from within a subject is disclosed. The device
comprises a support unit and a tissue retrieving net system. The
net system is carried by the support unit and may be inserted into
the subject through an orifice or small incision and operated to
retrieve tissue that has been severed by a conventional method. The
net system comprises a net, a net actuator, a net deployment and
retrieval assembly for transmitting motion between the net and its
actuator. The net system further comprises at least one net
connector disposed such that only one connector is within an
articulation zone, defined by locations of severe bending of the
device during operation.
Inventors: |
Secrest; Dean J. (Concord,
OH), Younker; Marlin E. (West Palm Beach, FL) |
Assignee: |
U.S. Endoscopy Group, Inc.
(Mentor, OH)
|
Family
ID: |
26843742 |
Appl.
No.: |
10/146,273 |
Filed: |
May 15, 2002 |
Current U.S.
Class: |
606/114; 606/113;
606/200 |
Current CPC
Class: |
A61B
17/00234 (20130101); A61B 17/221 (20130101); A61B
2017/2212 (20130101); A61B 2017/00287 (20130101) |
Current International
Class: |
A61B
17/22 (20060101); A61B 17/00 (20060101); A61B
017/24 () |
Field of
Search: |
;606/113-114,117,127,200 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Ho; (Jackie) Tan-Uyen T.
Attorney, Agent or Firm: Watts Hoffmann Co.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This non-provisional application claims benefit of U.S. Patent
Provisional Application Ser. No. 60/292,168, entitled "Retrieval
Device," filed on May 18, 2001.
Claims
What is claimed is:
1. An endoscopic surgical device for retrieving severed tissue or
foreign bodies from within a human body, the device comprising: a.
a support unit comprising: i. a body having a first passage
therethrough, and ii. an elongated introducer member having a first
end section proximal and fixed with respect to said body and a
second end section remote from the body, the introducer member
having a second passage aligned with the first passage and opening
at said second end section; and b. a tissue retrieving net system
comprising: i. a net comprising a wire-like resilient loop and a
net element having a mouth section slidably disposed on the loop
and a tissue receiving pouch section, said loop terminating with
two relatively parallel loop cables, said net disposed adjacent
said second end section for deployment and retraction through said
opening; ii. a net deployment and retrieval assembly extending
substantially through said first and second passages and connected
to the net, said assembly comprising a motion transmitting member
extending in said second passage to said loop; and iii. a net
actuator unit comprising a first handle fixed with respect to said
body and a second handle fixed with respect to said motion
transmitting member and movable relative to said first handle so
that shifting the second handle relative to said first handle
shifts said net into and out of said opening; c. said second
passage having a diametrical extent substantially smaller than the
width of said loop as deployed, said introducer member engaging
said loop at said opening and resiliently collapsing and elongating
said loop as said net is retracted and moves into said second
passage, said loop resiliently returning to its uncollapsed
configuration as it is deployed; d. said net system further
comprising a connector, wherein the connector secures each loop
cable; e. wherein with respect to said support unit, a proximal
portion of said net element is secured to the motion transmitting
member on the proximal side of the connector, and a distal portion
of said net element is secured to a center portion of said
loop.
2. The device claimed in claim 1 wherein said deployment and
retrieval assembly comprises a thin, flexible wire-like motion
transmitting member between the net actuator unit and the loop,
said motion transmitting member extending within an introducer
guide passage, said introducer guide passage closely surrounding
said motion transmitting member and constraining said member for
translational longitudinal motion within said passage.
Description
FIELD OF THE INVENTION
The present invention relates to surgical devices and more
particularly to endoscopic retrieval devices constructed for
retrieving relatively small pieces of sample tissue or foreign
bodies from a human subject through orifices or small
incisions.
BACKGROUND OF THE INVENTION
Snares, baskets, and graspers are in widespread use for severing
capturing and retrieving tissue specimens and foreign bodies from
within subjects. The devices are used in human and animal subjects,
in laparoscopic surgeries and other procedures where access within
a subject is only possible via a small opening. One exemplary use
is for cutting off and retrieving intestinal polyps where a wire
snare, passed through an colonoscope instrument channel, encircles
and is tightened about an intestinal polyp to sever the polyp. The
severed polyp is retrieved in a net inserted through the instrument
channel. The net is manipulated to enclose the polyp and then
withdrawn with the instrument so that the tissue architecture
remains undisturbed.
In this procedure, as well as others, the net and snare must be
quite compact in order to pass into the subject through the
instrument channel, or other passage. Prior art proposals have
employed snares supported within plastic tubes that were snaked
into the subject to locate the snare where desired. The snare was
then deployed from its tube, manipulated to cut off the polyp and
retrieved into the tube for removal from the subject.
A net, collapsed within another tube, was introduced through the
instrument channel, etc., for removing the polyp. When near a
target polyp, the net was deployed, like the snare, and manipulated
to net the polyp. The net was then closed sufficiently to secure
the polyp and withdrawn from the subject.
U.S. Pat. No. 5,643,283 to Younker, which is incorporated herein by
reference in its entirety, discloses a device for retrieving an
object from within a subject. The device comprises a shaft and a
compressible pouch for receiving the object positioned adjacent a
distal end of the shaft. The pouch includes a mouth which can be
opened and closed. The pouch is retained, in proximity to the
distal end of the shaft, on a cable loop by a slidable tether. The
net is free to slide on the cable loop to form a pouch at the
distal end of the shaft. The tether is fixed at a second location
near the proximal end of the shaft, and in one embodiment, is tied
off to a ring and secured with heat shrink tubing. When the
targeted foreign object is within the pouch, a clinician disengages
the ring portion of the handle to close the net around the object.
The clinician then removes the device from the patient and unloads
the object from the net. The clinician then places the ring on a
post, in order to pack the pouch into the distal end of the
shaft.
In operation of a commercial embodiment of U.S. Pat. No. 5,643,283,
several problematic issues have surfaced. Clinicians have
experienced difficulty in understanding the operation of the
tether, in particular, the interaction of the ring and post. The
ring is to be used to pull the net inside the shaft only when an
object is not within the net. In preparation to capture an object,
the ring should be disengaged to release the net. The net is then
slid over the targeted object and the net is closed. At this point,
proper operation would involve merely removing the device from the
patient. However, some clinicians when operating the device try to
further pull the net inside the shaft when the net is bundled up at
distal end of cable loop. This will cause the net to jam, or in
some cases, damages the tubing. The occasional improper operation
of the device sometimes causes permanent malfunction.
The commercial embodiment discussed above also adds undesirable
expense to the product. Specifically, the full length tether and
heat shrink operation add material cost and labor assembly cost to
the device.
The present invention provides a new and improved retrieval device
that is so constructed and arranged that net movement during
deployment and retrieval is not prohibitively restricted. Secure
net attachment is assured and that provides for convenient net
packing in the introducer passage. The device provides a convenient
and economical method of sample retrieval during endoscopic
procedures. The new retrieval device is easy assemble, manufactured
at a reduced cost, and easier to use by the end consumer.
SUMMARY OF THE INVENTION
In one illustrated embodiment of the present invention an
endoscopic surgical device for retrieving severed tissue from
within a human subject is provided. The device includes a support
unit and a tissue retrieving net system.
The support unit includes a body and an elongated introducer
member. The body defines a first passage therethrough. The
introducer has a first end section proximal and fixed with respect
to the body and a second end section remote from the body. The
introducer member further defines a second passage aligned with the
first passage and opening at the second end section.
The tissue retrieving net system includes a net, a net deployment
and retrieval assembly and a net actuator system.
The net includes a wire-like resilient loop and a net element
having a mouth section slidably disposed on the loop and a tissue
receiving pouch section. The loop terminates with two relatively
parallel loop cables. The net is disposed adjacent the second end
for deployment and retraction through the second passage
opening.
The net deployment and retrieval assembly extends substantially
through the first and second passages and connects to the net. The
assembly further includes a motion transmitting member extending in
the second passage to the loop.
The net actuator unit includes a first handle fixed with respect to
the body and a second handle fixed with respect to the motion
transmitting member and movable relative to the first handle. The
act of shifting the second handle relative to the first handle
shifts the net into and out of the second passage opening.
The introducer member second passage has a diameter substantially
smaller than the width of the loop as deployed. The member engages
the loop at the second end section opening and resiliently
collapses and elongates the loop as the net is retracted and moves
into the introducer member passage. The loop resiliently returns to
its uncollapsed configuration as it is deployed.
In one embodiment, the net system includes at least one connector
adapted to fasten each loop cable. The ends of the net element are
secured to the motion transmitting member on the proximal side of
the at least one connector with respect to the support unit.
In a second embodiment, the net system further includes a first
connector, a second net connector proximal to the second passage
opening, and an intermediate portion defined by an axial space on
the loop cables between the first connector and the second
connector. The first connector and the second connector are adapted
to fasten each loop cable. Ends of the net element are secured to
the loop within the intermediate loop portion between the first
connector and the second connector.
The deployment and retrieval assembly may include a thin, flexible
wire-like motion transmitting member between the net actuator unit
and the loop. The motion transmitting member extends within an
introducer guide passage which closely surrounds the motion
transmitting member and constrains the member for translational
longitudinal motion within the passage.
The first connector may be disposed at least 6 inches from the
second connector, such that only one connector is within an
articulation zone during deployment of the net element.
The ends of the net element may be secured to the motion
transmitting member adjacent a proximal shoulder of the connector
with respect to the support unit.
The present invention offers advantages over devices available in
the prior art. In a second embodiment, the net is fixed distally
and proximally by the use of a first and second connector. The
connectors are sufficiently spaced apart to provide secure net
attachment without the use of additional tether mechanisms. The
connectors are positioned such that only one may be within an
articulation zone of the endoscope at a time, permitting ease of
net deployment in a variety of geometric operating
configurations.
In a first embodiment, only one connector is used to secure the
proximal side of the net. This technique decreases the amount of
cable loop length within the articulation zone. The reduction in
cable loop length effectively reduces the amount of rigid material
within the articulation zone of the endoscope at a time, further
permitting ease of net deployment in a variety of geometric
operating configurations.
The device is also easier to assemble and less expensive to
manufacture than certain conventional designs.
Further features and advantages of the invention will become
apparent from the following detailed description made with
reference to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an elevational view of a surgical device constructed
according to one embodiment of the present invention, illustrated
with the net element deployed;
FIG. 2 is a view similar to FIG. 1, illustrated with the net
element retracted;
FIG. 3 is an enlarged fragmentary view of a part of the device
illustrated in FIG. 1, showing detail of the introducer member;
FIG. 4 is a enlarged fragmentary view of part of the device
illustrated in FIG. 1, with the device show as positioned in a
sample configuration within a subject;
FIG. 5 is an enlarged fragmentary view of part of a surgical device
constructed according to a second embodiment of the present
invention, showing detail of the introducer member, and
FIG. 6 is a enlarged fragmentary view of part of the device
illustrated in FIG. 5, with the device show as positioned in a
sample configuration within a subject.
BEST MODE CONTEMPLATED FOR CARRYING OUT THE INVENTION
An endoscopic surgical device 10 for retrieving severed tissue and
or foreign bodies from within a subject is illustrated by the
drawings. Referring to FIGS. 1 and 2, in one embodiment, the device
10 comprises a support unit 12 and a tissue retrieving net system
16. The net system is carried by the unit 12 and is so constructed
and arranged that it may be inserted into the subject through an
orifice or small incision and operated to retrieve a tissue sample
previously detached from the subject by a conventional method,
e.g., a snare/cautery system. Accordingly, the net system 16
comprises a net 20, a net actuator 24, and a net deployment and
retrieval assembly. 28 for transmitting motion between the net and
its actuator 24. The net 20 comprises a net element 21 and a net
loop 22 and a distal 25 and proximal 26 tie off suture that secures
the net.
The device 10 can be used with any suitable or conventional
endoscopic or laparascopic surgical equipment. For purposes of this
disclosure the device 10 is described in the context of use with an
endoscope/colonoscope/sigmoidoscope type apparatus (not
illustrated), of conventional or suitable construction. The scope
is provided with an elongated body having a controllably flexible
projecting end region. Surgical instruments, such as the device 10,
may be introduced through an instrument channel, which extends
through the scope body, for retrieving tissue targeted by the
surgeon manipulating the scope.
The support unit 12 supports the net system 16 so that the net 20
can be inserted through the scope instrument channel by a surgeon.
The support unit 12 comprises a body 30 defining a passage and an
elongated introducer 40 having a first end section 42 proximal and
fixed with respect to the body 20 and a second end section 44
remote from the body. The introducer 40 is tubular and aligned with
the body passage for receiving the net system.
The illustrated introducer 40 is a smooth, supple member capable of
being snaked through the scope instrument channel into the subject
and readily flexed into any shape required as the scope body is
flexed by the surgeon. In the illustrated embodiment, the
introducer 40 is a generally cylindrical, small diameter tube
formed of non-reactive low friction plastic material, such as
polytetrafluouroethylene. The first end section 42 is fixed to the
body 30 while the second end section 44 houses the net for
individual deployment and retrieval.
The net actuator 24 is adapted for reciprocating the deployment and
retrieval assembly in the body and introducer to operate the net
20. The actuator 24 comprises a first handle 50 fixed with respect
to the body 30 and a second handle 52 attached to the deployment
and retrieval assembly 28 and movable with respect to the handle
50.
The second handle 52 is fixed to the assembly 28 and mounted on the
handle 50 between its ends for longitudinal sliding movement. The
second handle comprises a dual finger ring member 80 slidable on
the handle 50. The handles 50, 52 as illustrated are formed from
molded plastic materials.
The deployment and retrieval assembly 28 is constructed and
arranged to transmit considerable deployment and retractive forces
to the net while enabling the scope body to be freely manipulated
and flexed to position the net where desired. The assembly 28
comprises a link comprises a first link section 70 and a second
link section 71 connected to the actuator 24 for transmitting
compressive and tensile forces between the handle 52 and a bore 58.
The bore 58 is disposed within the center of the body 30. The link
70 transmits relatively substantial compressive forces without
bending or breaking. The illustrated first link section 70 is
formed from hypodermic needle stock, i.e., it is a cylindrical
stainless steel tube. The second link section 71 as illustrated is
a multi-strand cable. The first link section 70 joins the second
link section 71 as the link exits the body 30.
The link 71 extends from the body 30 and within the introducer 40
so that it must flex with the introducer yet transmit compressive
and tensile forces. The illustrated link 71 is closely surrounded
by the body passage of the introducer passage 40. The link 71 is
relatively stiff compared to the supple introducer. When
transmitting compressive forces, the link 71 is resiliently
deformed to bow against the introducer wall. The link 71 has good
compressive and tensile strength and is somewhat resiliently
bendable. The link 71 will bend appreciably without yielding and
kinking.
A first connector 80 and a second connector 82 fix the loop 22 in
two locations with respect to the net 20. The proximal side of the
net is tied off at a location 85 between the loop cables. As
illustrated in FIG. 3, a tether 27 is used to tie off the proximal
side of the net. This tether is shorter than conventional tethers
that travel the full length of the introducer. No further tethering
system is required, although additional net mounting techniques may
be employed in the practice of the invention.
Referring now to FIG. 3, the first connector 80 joins the link 71
and the loop 22 together structurally. The illustrated connector 80
is a short tube crimped to both ends of the loop 22 and to the
second link section 71, The illustrated connector tube is crimped
about the loop and link to form a cross sectional shape, which is
capable of rotating within the introducer 40. The illustrated
connector 80 is formed from hypodermic needle stock, like the first
link section 70. The second connector 82 further joins opposing
portions on the net loop 22 at a location proximal to the net 20
with respect to the first connector 80.
In the illustrated embodiment, the space between the two loop
cables is utilized to fix the net element 21 with respect to the
link 71. An intermediate region R, shown in FIG. 3, axially between
the first connector 80 and the second connector 82 within the
introducer 40 may be used. In an exemplary embodiment, the proximal
side of the net element 21 with respect to the support system 12 is
fixed to the net loops 22 at a convenient location 85. Suture
material, or another known suitable method, may be used to tie the
net to the loop.
The net 20 is deployed from the introducer second end 44 and
manipulated by the surgeon to net severed tissue and secure the
tissue for retrieval from the subject. The net 20 may be deployed
after a snare or similar technique has severed the target tissue.
The net 20 comprises a pouch-like net element 21 slidably supported
on the loop 22.
The illustrated net loop 22 is formed from a loop of fine wire
constructed and arranged to cooperate with the introducer to deploy
and retract the net 20. The illustrated loop 22 is a stiff,
resilient flexible wire having its respective ends crimped in place
in two locations by the first and second connector 80, 82. When the
net is deployed from the end of the introducer, the loop
resiliently expands to a relaxed condition where the loop width is
substantially greater than the introducer diameter. The deployed
snare is guided to a position where it receives a target polyp or
other tissue. The net is retracted by the surgeon. As the net is
retracted into the introducer second end 44 the loop resiliently
bears against the introducer wall so the loop resiliently
collapses, narrowing the loop portion projecting from the
introducer. Tissue or another object captured within the net
element 21 is progressively constricted by the elastic nature of
the net, allowing for a wide range of sized objects to fit inside
the net without compromising the architecture preservation or the
security of the object, as the net is being drawn toward the distal
end of the introducer.
The net element 21 is an extremely light pouch-like structure
having the net loop wire extending through the mesh about its
periphery to form a net mouth slidably supported on the loop and a
depending pouch. The net fibers are quite fine, yet sufficiently
strong that the net element may slide along the loop wire in the
direction away from the connectors 80, 82 to enclose tissue within
the pouch as the net is retrieved and/or to gather the entire net
at the distal net loop end when the net loop has been retrieved.
The net has minimal bulk so that when an empty net is retrieved, it
easily moves completely into the introducer passage.
The illustrated net is formed from 100% nylon fibers having strand
diameters of from about 0.0125 mm-0.04 mm. The fibers are woven in
a diamond mesh pattern with the mesh strands spaced from 1 mm-3 mm
and their intersections fixedly secured together. The illustrated
netting material is substantially like that of a fine mesh hair
net. The net is formed by cutting about a square, circular or
elliptical section of the net, trimming or otherwise finishing the
edges and threading the loop wire through the peripheral mesh
elements. The cut net section size is selected sufficiently larger
than the net loop area to assure that a pouch-like, tissue
receiving portion suspends from the net mouth, but not too large to
create undesirable bulk and difficulty packing the net when pulling
it inside the shaft.
Attempting to fully retrieve a tissue containing net into the
introducer 40 can result in tissue loss by forcing the tissue
through the net. The net fibers are fine and strong so they may cut
the tissue or they may be broken, either of which alternative is
undesirable. A net actuator thumb ring may be provided with a tag
(not illustrated) warning the surgeon not to continue retrieving
the net against unusual resistance.
The present invention resolves problems faced by surgeons and
nurses working with some prior art designs. Nurses and doctors have
experienced difficulty in understanding the operation of the
tether, specifically the interaction of the ring and post.
Therefore, occasionally the device is operated incorrectly causing
malfunction. The present design allows a nurse to pull back on the
handle to conveniently pack the net inside the introducer
passage.
Further, often a surgeon is required to manipulate the endoscope
into difficult to access internal areas. Certain procedures require
bending or twisting the endoscope. The area of the endoscope that
is twisted or bent is called the articulation zone.
Some net devices have featured multiple connector designs in which
the connectors are spaced somewhat adjacently with the second end
section 44. In these designs, the multiple connectors on the net
devices have resisted bending of the scope. Moreover, the friction
created has made deployment of the net difficult once the scope has
been desirably positioned by the surgeon. One advantage of the
present invention is increased freedom of movement, and ease of net
deployment, within the articulation zone.
During operation of the system 10, the surgeon experiences an
increased ease of use over prior art designs. In the illustrated
embodiment, the first connector 80 is axially disposed a distance
from the second connector 82, such that only one connector is
within the articulation zone (bounded by A.sub.1,A.sub.2), defined
along the introducer 40 longitudinal axis, during deployment of the
net element. In the illustrated system, the first connector 80 is
disposed at least six inches from the second connector 82.
The articulation zone defines the axial portion of the introducer
40 within a substantially non-linear position. The articulation
zone typically includes bends of greater than 30.degree. and can
exceed 200.degree. at a radius of 0.75 inches or less.
Referring to FIG. 4, a portion of the system 10 is illustrated as
positioned in a probable configuration within a subject. During
operation of the scope, a surgeon may manipulate the second end
section 44 of the introducer into a severe articulated position. At
times, the second end section may be bent up to 180.degree., as
illustrated in FIG. 4. Deployment of the net 20 in this and similar
positions is difficult when the connectors 80, 82 are both within
the articulation zone. The combined kinetic frictional force of
each connector against the inside of the introducer passage would
otherwise make deployment of the net difficult. As illustrated in
FIG. 4, the surgeon more easily deploys the net in a variety of
positions.
A second embodiment of the present invention is illustrated by the
drawings. A part of an endoscopic surgical device 10 for retrieving
severed tissue and or foreign bodies from within a subject is
illustrated in FIGS. 5 and 6. In this illustrated design, the
device 10 includes a support unit 12 and net actuator 24 as
previously described. However, an alternative construction of a net
deployment and retrieval assembly 28 is utilized.
In the illustrated design, the net deployment and retrieval
assembly 28 uses a single connector. Referring now to FIG. 5, the
connector 182 joins the link 71 and the loop 22 together
structurally. The illustrated connector 182 is a short tube crimped
to both ends of the loop 22 and to the second link section 71. The
illustrated connector tube is crimped about the loop and link to
form a cross sectional shape, which is capable of rotating within
the introducer 40. The illustrated connector 182 is formed from
hypodermic needle stock, like the first link section 70.
One goal of the design is to reduce the amount of rigid material
within the articulation zone. During operation of the system 10,
the surgeon experiences an increased ease of use over prior art
designs. As illustrated in FIG. 6, the length of rigid material
within the articulation zone (bounded by A.sub.1,A.sub.2), defined
along the introducer 40 longitudinal axis, is minimized during
operation of the net element. The reduction in rigid material
results from reducing the length of loop cable 22 within the
articulation zone.
As shown in FIG. 5, the proximal side of the net element 21 with
respect to the support system 12 is fixed to the net loops 22 at a
convenient location 185. Suture material, or another known suitable
method, may be used to tie the net to the loop. As illustrated in
FIG. 5, a tether 27 is used to tie off the proximal side of the
net. This tether is shorter than conventional tethers that travel
the full length of the introducer. The tether 27 may be tied off
adjacent the shoulder of the connector 182. As shown, the tether
has a diameter not greater than the thickness of the connector
shoulder. No further tethering system is required, although
additional net mounting techniques may be employed in the practice
of the invention.
While two embodiments of the invention has been illustrated and
described in considerable detail, the present invention is not to
be considered limited to the precise constructions disclosed.
Various adaptations, modifications and uses of the invention may
occur to those skilled in the arts to which the invention relates.
It is the intention to cover all such adaptations, modifications
and uses falling within the scope or spirit of the annexed
claims.
* * * * *